The Australian regulatory body the Therapeutic Good Administration (TGA) has announced that following further investigation into the association between BIA-ALCL and textured breast implants it is now proposing that all textured breast implants are banned from use in Australia.
The TGA’s proposed ban is supported by the Australian Health Minister. Under Australian law, all manufacturers affected by the ban will have until 24 July 2019 to respond to the proposed ban.
After that date the proposed ban may be made permanent.
Why is this announcement from Australia important?
- The proposed Australian ban includes all textured implants: As such, it mirrors the precautionary action taken in France and Canada in relation to textured breast implants. By contrast our own regulator, the MHRA has chosen only to include Allergan textured breast implants within the scope of the UK ban. This means that other textured breast implants, including those manufactured by Nagor are still available within the UK market.
- The Australians have some of the best quality breast implant data in the world: Since 2011 Australian regulators and clinicians have collaborated to establish an ‘opt out’ registry for all surgeons performing breast implant surgeries throughout Australia (and New Zealand). By contrast, the Breast and Cosmetic Implant Registry (BCIR), used in the UK, has only been in operation since October 2016 and is an ‘opt in’ or voluntary registry which means that the amount and quality of the data that it captures is still very poor. As a consequence, in contrast to the Australian registry, the BCIR is not yet mature enough to provide regulators with good quality data on the performance of breast implants and any problems that arise in association with them.
- The Australian announcement is a response to the fact that there are now 78 confirmed cases of BIA-ALCL in Australia: This figure includes 4 deaths, and means that the Australian regulator has confirmed that the risk incidence of developing BIA-ALCL for women with breast implants is between 1:1000 and 1:10,000, based upon their review of Australian registry data. By contrast the MHRA continue to report the risk of BIA-ALCL as 1:24,000 for women in the UK with all types of implants.
- The proposal to ban all textured implants, not just Allergan, acknowledges that the BIA-ALCL cases reported in Australia are likely to relate to a variety of textured implants, including, but not limited to Allergan.
In this context, the fact of the Australian proposal prompts important questions for our own regulator, which still remain unanswered:
- Why did it take so long for the Breast Implant and Cosmetic Surgery Registry to be established in the UK?
- Why didn’t we adopt the ‘opt out’ methodology used in Australia?
- Why, in contrast to other jurisdictions with better quality data, does the UK ban not include all textured implants?
We are currently representing a group of women in potential legal action relating to the Allergan textured implants who have been diagnosed with BIA-ALCL. We hope that the MHRA are taking careful consideration of this latest ban in Australia and look forward to further information being provided by the Australian regulator after the deadline of July 24.